← FDA Drug Approvals (Drugs@FDA)
SAFYRAL
NDA · New Drug Application · Sponsor: BAYER HLTHCARE · Approved 2010-12-16
Drug application
- FDA Application #
NDA022574- Application type
- New Drug Application
- Brand name
- SAFYRAL
- Generic name
- DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM
- Active ingredients
- DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- BAYER HLTHCARE
- Manufacturer
- Bayer HealthCare Pharmaceuticals Inc.
- First approval
- 2010-12-16
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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